Infectious Risk of Vaginal Ultrasound Examination: Evaluation and Modeling From Human Papillomavirus (HPV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Percentage and 95 % confidence interval of TVS procedures with covered probe positive for HPV
研究概览
简要总结
Multicenter observational survey of the presence of Human Papilloma Virus (HPV) on trans vaginal ultrasound (TVUS) probes, and of the behavior of professionals during US examination and probe disinfection. This will allow modeling the risk of HPV transmission, and could contribute establishing future guidelines for reducing the risk of transmission of microorganisms and the risk of infection through TVS.
详细描述
Prevention of infection Endo Vaginal sonography. Brief Summary
Background Trans vaginal sonography (TVS) is widely used in obstetrics and gynecology. Because of the relative lack of data, there is no universal agreement on how to prevent the transmission of pathogens and the risk of infection through TVS. Whereas American guideline are more stringent, French health authorities recommend low-level disinfection of the probe between two patients with the use of probe cover, and intermediate level disinfection at least once daily and in case of visible contamination of the probe, or rupture of the probe cover. For the coupling gel, guidelines do not agree on whether or not it should be sterile.
Transmitting infectious agents may result from a variety of causes: failure to disinfect the probe, contaminated gel, contamination of the probe cover due to incorrect manipulation and failure to comply with hand washing or disinfection.
Due to resistance to disinfection, high prevalence, and potential oncogenic role, we will use HPV as a marker for the presence of pathogens on the probe, the probe cover, and the environment.
Objectives Primary objective: to assess the presence of HPV on bare probes and on probes with their probe-cover in routine practice
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All examination of endo-vaginal ultrasound performed at participating center during a predetermined observation session,
排除标准
- •* Endo-Vaginal ultrasound with invasive procedure (with cutaneous or mucosal break)
- •Refusal of the patient that non-personal data are addressed in a study,
结局指标
主要结局
Percentage and 95 % confidence interval of TVS procedures with covered probe positive for HPV
时间窗: 12 months
Qualitative variable. Statistical unit: each procedure surveyed
Percentage and 95 % confidence interval of TVS procedures with bare probe positive for HPV
时间窗: 12 months
Qualitative variable. Statistical unit: each procedure surveyed
次要结局
- Percentage of procedures with keyboard positive for HPV(12 months)
- Percentage of procedures with visibly tainted probes(12 months)
- Percentage of presence of each disinfection guideline item since last procedure and before the probe is tested for the presence of HPV(12 months)
- Percentage of centers with a written protocol complying with disinfection guidelines(12 months)
- Percentage of procedures with visible rupture of probe cover(12 months)
- Percentage of procedures with visibly tainted probes during previous procedure(12 months)
- percentage of centers with traceability of disinfection procedures.(12 months)
- Percentage of procedures with visible rupture of probe cover during previous procedure(12 months)